FDA Adverse Event
Malfunction
Summary report: N
ROLLATORS-615
MDR report key: 19348131
·
Received May 18, 2024
Report
- Report Number
- 3014644996-2024-00009
- Event Type
- Malfunction
- Date Received
- May 18, 2024
- Report Date
- May 18, 2024
- Manufacturer
- COM-DA HEALTHCARE CO.,LTD
- Product Code
- ITJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
CUSTOMER HAS A ROLLING WALKER THE PIN THAT GOES THRU THE HOLE FELL OFF FRONT LEFT WHEEL AND THE WALKER COLLAPSED AND CAUSED HER TO FALL OVER ON THE WALKER NO MEDICAL ATTENTION RECEIVED, HER DAUGHTER IS A NURSE AND NO INJURIES OCCURRED, MINOR BRUISING. BELIEVES THIS WAS PURCHASED LAST MARCH BUT UNSURE WHERE FROM
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 642664 | ROLLATORS-615 | WALKER | ITJ | COM-DA HEALTHCARE CO.,LTD | 1-FGA22100 0000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 97 YR | Unknown |